Observation Study: Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients

Inclusion Criteria:Patients must meet all of the following inclusion criteria in order to be entered into the study:

• Age 20 or older.
• Patient has signed informed consent.

• Patient must have a diagnosis of hepatocellular cancer confirmed by AASLD and at least one of the following method:

  • Magnetic resonance imaging (MRI) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm.
  • Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion > 1 cm.
  • Histological confirmation is required for lesions with inconclusive features.

• Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.

  • Patients not suitable for ablation due to lesion location may be enrolled.
  • Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled.

• Patient MUST be with either BCLC stage B OR C, and meet the following criteria:

  • Stage Child-Pugh A or B AND
  • Performance status ECOG ≤ 1 WITH Vascular Invasion or WITHOUT Vascular invasion.
• Patient has a life expectancy of at least 6 months.

Exclusion Criteria:If patients meet any of the following criteria they may not be entered into the study:

• Current or previous treatment with chemo- or radiation therapy or sorafenib or drug-eluting chemoembolization (deTACE).
• Patients with concurrent cancer except non-melanomatous skin cancer.
• Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive.
• Performance status ECOG > 1.
• Child-Pugh Class C.
• Occlusive tumor thrombus to the main portal trunk.
• Active gastrointestinal bleeding.
• Evidence of uncorrectable bleeding diathesis.
• Extra-Hepatic spread of the HCC.
• Encephalopathy not adequately controlled medically.
• Presence of ascites not controlled medically.
• Any contraindication for MRI/ CT (eg. metallic implants).
• Allergy to contrast media that cannot be managed with prophylaxis.
• Any contraindication to arteriography.
• Any contraindication for doxorubicin administration.
• Any contraindication for hepatic embolization. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization. Hepatofugal blood flow. Serum creatinine > 2mg/dL. Other condition deemed exclusionary by physician. Uncorrectable impaired clotting.